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| Tracking Information | |||||
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| First Received Date ICMJE | October 8, 2008 | ||||
| Last Updated Date | May 9, 2009 | ||||
| Start Date ICMJE | February 1993 | ||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Value of the pre-operative Gleason score, prostate-specific antigen level, and clinical stage in predicting the risk of failure and death [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00769223 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Gleason Score, Prostate-Specific Antigen Level, and Cancer Stage in Predicting Outcome in Patients Who Have Undergone Radiation Therapy for Localized Prostate Cancer | ||||
| Official Title ICMJE | Pre-Operative Gleason Score and PSA and Clinical Stage in Predicting the Risk of Failure in Patients Undergoing Radiation Therapy for Localized Prostate Cancer | ||||
| Brief Summary | RATIONALE: Gathering information about the Gleason score, prostate-specific antigen (PSA) level, and cancer stage from patients who have undergone radiation therapy for prostate cancer may help doctors predict how patients respond to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying the Gleason score, PSA level, and cancer stage in predicting outcome in patients who have undergone radiation therapy for localized prostate cancer. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patient medical records are reviewed to collect data about pre-treatment prostate biopsy, assigned Gleason score, prostate-specific antigen level, and radionucleotide bone scan. Patients complete a Bowel Toxicity questionnaire to assess quality of life related to acute and long-term bowel toxicity after radiotherapy. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3500 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | February 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00769223 | ||||
| Responsible Party | Mack Roach, III, UCSF Helen Diller Family Comprehensive Cancer Center | ||||
| Study ID Numbers ICMJE | CDR0000597000, UCSF-H7056-08989 | ||||
| Study Sponsor ICMJE | UCSF Helen Diller Family Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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